Ultrasound-guided alignment and insertion of percutaneous cannulating instruments

Abstract

A device and method for directing a cannula toward a target location under a patient's skin. The device is handheld and the device operations may be automated. The device includes an imaging probe for imaging the target location, a positioning unit for manipulating a cannula towards the target location, and a processor. The processor receives imaging data from the imaging probe, cannula pose data from at least one cannula position sensor, and device pose data from at least one device position sensor. The target location is identified from the imaging data, and a trajectory for manipulating the cannula towards the target location is determined based on the imaging data, the cannula pose data, and the device pose data. The processor may determine that the trajectory becomes misaligned with the target position, and may update to a corrected trajectory based on the imaging data, cannula pose data, and device pose data.

The invention claimed is: 
     
       1. A device for directing a cannula toward a target location under a patient's skin, the device comprising:
 at least one motor configured to manipulate a cannula in a lengthwise direction of the cannula towards a target location corresponding to a target vessel for cannulation, 
 a set of sensors configured to:
 detect an amount of force exerted on the cannula and generate force data indicative of a force applied to the device; 
 generate cannula pose data indicating a position of the cannula based on movement of the at least one motor; and 
 generate a set of images that capture an under skin region extending along a length of the patient's arm; and 
 
 a processor configured to determine whether the cannula will achieve successful insertion into the target vessel at the target location under the patient's skin by: 
 receiving the force data, the cannula pose data, and the set of images from the set of sensors; 
 determining a coordinate position for the target location corresponding to the target vessel based on a combination of the received force data, cannula pose data, and set of images; 
 generating a trajectory to the coordinate position for the cannula; and 
 monitoring the manipulation of the cannula towards the coordinate position along the generated trajectory using the set of sensors. 
 
     
     
       2. The device of  claim 1 , wherein the set of sensors includes one or more force sensors including a material having a property that changes in response to an applied force. 
     
     
       3. The device of  claim 1 , wherein the set of sensors includes a current sensor configured to measure an electrical current in the at least one motor, wherein electrical current in the at least one motor increases proportionally to a load on the motor. 
     
     
       4. The device of  claim 1 , wherein the at least one motor includes a plurality of motors, and wherein the set of sensors includes a plurality of motor sensors, each motor sensor associated with a corresponding one of the plurality of motors to generate the cannula pose data. 
     
     
       5. The device of  claim 1 , wherein the processor is configured to: determine an adjustment to the cannula that reduces a likelihood of failure of the successful insertion based on the combination of the received force data, cannula pose data and set of images. 
     
     
       6. The device of  claim 1 , wherein the set of images comprise two-dimensional imaging data from a plurality of angles, and wherein the processor is further configured to perform at least one of:
 constructing three-dimensional imaging data from the two-dimensional imaging data; and 
 determining a three-dimensional pose for insertion into the target under the patient's skin from the two-dimensional imaging data. 
 
     
     
       7. The device of  claim 1 , wherein the set of sensors includes an ultrasound probe configured to generate the set of images, wherein the set of images includes imaging data generated by the ultrasound probe, and wherein the imaging data is one of: two-dimensional imaging data, volumetric three-dimensional imaging data, and biplanar imaging data. 
     
     
       8. The device of  claim 1 , wherein the processor is configured to:
 generate a force profile from force data received from the set of sensors; and 
 classify the generated force profile as one of a successful cannulation event or an unsuccessful cannulation event; and 
 upon occurrence of an unsuccessful cannulation event, instruct the one or more motors to manipulate the cannula in a reverse direction. 
 
     
     
       9. The device of  claim 8 , wherein classification of the force profile is based on a comparison of the force data against pre-stored force data profile information. 
     
     
       10. The device of  claim 8 , wherein the processor is configured to, upon occurrence of an unsuccessful cannulation event:
 classify the generated force profile as one of a vessel rolling event, an undershoot event, and an overshoot event; and 
 control repositioning of the cannula according to the classified vessel rolling event, undershoot event, or overshoot event. 
 
     
     
       11. The device of  claim 1 , further comprising at least a second motor configured to manipulate the cannula in a second axis of movement different from the lengthwise direction. 
     
     
       12. The device of  claim 1 , wherein the at least one motor is configured to manipulate the cannula in the lengthwise direction at a predetermined speed. 
     
     
       13. A method for directing a cannula toward a target location under a patient's skin, the method comprising:
 manipulating, by at least one motor, a cannula in a lengthwise direction of the cannula towards a target location corresponding to a target vessel for cannulation, 
 generating, by a set of sensors:
 force data indicating an amount of force exerted on the cannula; 
 cannula pose data indicating a position of the cannula based on movement of the at least one motor; and 
 a set of images that capture an under skin region extending along a length of the patient's arm; 
 
 determining, by a processor, whether the cannula will achieve successful insertion into the target vessel at the target location under the patient's skin by: 
 receiving, by the processor, the force data, the cannula pose data, and the set of images from the set of sensors; 
 determining, by the processor, a coordinate position for the target location corresponding to the target vessel based on a combination of the received force data, cannula pose data, and set of images; 
 generating a trajectory to the coordinate position for the cannula; and 
 monitoring the manipulation of the cannula towards the coordinate position along the generated trajectory using the set of sensors. 
 
     
     
       14. The method of  claim 13 , wherein the at least one motor includes a plurality of motors, and wherein the set of sensors includes a plurality of motor sensors, the method comprising each motor sensor generating the cannula pose data associated with a corresponding one of the plurality of motors. 
     
     
       15. The method of  claim 13 , further comprising:
 determining, by the processor, an adjustment to the cannula that reduces a likelihood of failure of the successful insertion based on the combination of the received force data, cannula pose data, and set of images. 
 
     
     
       16. The method of  claim 13 , wherein the set of images comprise two-dimensional imaging data from a plurality of angles, the method comprising at least one of:
 constructing three-dimensional imaging data from the two-dimensional imaging data; and 
 determining a three-dimensional pose for insertion into the target under the patient's skin from the two-dimensional imaging data. 
 
     
     
       17. The method of  claim 13 , wherein the set of images is generated by an ultrasound probe and includes imaging data that is one of: two-dimensional imaging data, volumetric three-dimensional imaging data, and biplanar imaging data. 
     
     
       18. The method of  claim 13 , further comprising:
 generating, by the processor, a force profile from the force data received from the set of sensors; 
 classifying, by the processor, the generated force profile as one of a successful cannulation event or an unsuccessful cannulation event; and 
 upon occurrence of an unsuccessful cannulation event, instructing, by the processor, the one or more motors to manipulate the cannula in a reverse direction. 
 
     
     
       19. The method of  claim 18 , the method comprising, upon occurrence of an unsuccessful cannulation event:
 classifying, by the processor, the generated force profile as one of a vessel rolling event, an undershoot event, and an overshoot event; and 
 controlling, by the processor, repositioning of the cannula according to the classified vessel rolling event, undershoot event, or overshoot event. 
 
     
     
       20. The method of  claim 13 , further comprising manipulating, by at least a second motor, the cannula in a second axis of movement different from the lengthwise direction. 
     
     
       21. The method of  claim 13 , manipulating, by the at least one motor, the cannula in the lengthwise direction at a predetermined speed.